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PROGRAMAS DE TREINAMENTO ONLINE PARA COMITÊS DE ÉTICA EM PESQUISA NO MUNDO. UM ESTUDO DE CASO
Institut de Droit de la santé
Prof. Dominique Sprumont
Institut de droit de la santé
Université de Neuchâtel
Sao Paulo, August 19, 2013
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
1. Introduction
2. Consensus Standards for Introductory e-Learning Courses in Research Ethics and Regulation
3. Introduction to the TRREE program (www.trree.org)
4. Q/A
OVERVIEW
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
1. Introduction
• Regulation of research involving human participants has evolved since the 1960’s when first rules appeared
• The model of self-regulation has become one of legislative regulation
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
1. Introduction (cont’d)
Regulation of Research Ethics Committees (REC) has also changed
– From self-appointed, REC have become
statutory/public (i.e. Europe) or institutional
committees (US)
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
1. Introduction (cont’d)
• Changes impacted the role of REC
– Selection criteria: qualification
– Quorum: established by regulatory authorities
– Operating procedures/functions (SOP): regulated
• RECs have new needs if they are to meet those requirements
• This is also true for investigators and other actors in the field
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
1. REC Needs
Members of a REC must
– Collectively be qualified in the scientific fields
– Individualy have certain qualifications (legal,
ethics, biostatistics, etc.)
– Evaluate projects with due process & deliberation
– Assess GCP compliance
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
1. REC needs (cont’d)
Training on:
– Principles of research ethics
– How to apply these principles
– REC work: process, deliberation, audit trail etc.
– GCP and broader regulatory context
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
• 1. Is the research project responding to the
specific health needs of the targeted population?
• 2. Will the research project have direct impact on
the use of local resources, especially in terms of
access to healthcare? Will this affect priorities in
public health programs?
• 3. Will the targeted population have access to the
tested intervention if it is proven beneficial?
2.2. The importance of the available resources in the ethical review process in developing countries
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
1. Existing Elearning programs• http://webcourses.amanet-trust.org/mod/resource/view.php?inpopup=true&id=116
• http://www.bioeticaweb.com/content/view/4197/91/
• http://www.bu.edu/online/programs/certificate-programs/clinical-investigationcourses.shtml
• http://BRANY.TrainingCampus.net
• http://www.ccac.ca/fr_/education/pnfiua
• http://www.csmls.org/CE/CE_course_details.cfm?ID=4658&&CFID=6835576-30697075
• https://www.citiprogram.org
• http://www.bioethicscolumbia.org/education/distance_learning.html
• http://www.epigeum.com/
• http://www.fhi360.org/resource/research-ethics-training-curriculum-retc-second-edition
• http://www.bioeticacs.org/?dst=curso_online
• http://www.menareti.net/
• http://www.estp.sci.eg/english/trainings/training_hretie
• http://www.kks-netzwerk.de/index,51,25,en,selten,x38hdt,,25.html
• http://www.thieme.de/viamedici/lernen/ethik/start.html
• http://www.cems.monash.org/online-ethics-training-course.html
• http://www.csl.uiuc.edu/ethics-center
• http://phrp.nihtraining.com/users/login.php
• http://ori.hhs.gov/education/products/montana_round1/research_ethics.html
• https://www.primr.org/Conferences.aspx?id=8523&ekmensel=297ded8b_421_0_8523_1
• http://ethique.msss.gouv.qc.ca/didacticiel/index.php?lang=fr_ca
• http://www.socra.org/html/education.htm
• http://www.redbioetica-edu.com.ar/
• http://www.fmv-uba.org.ar/cp/detallecurso.asp?idcurso=242
• http://www.onlinegcp.es/default.aspx?page=home
• http://www.admin.ox.ac.uk/researchsupport/ctrg/gcponline/registration/
University of Miami,
Ethics Programs
Online Courses in Research EthicsWorld Health Organization Network of Collaborating Centres in Ethics, December 2011https://umshare.miami.edu/web/wda/ethic
s/documents/WHO/online_courses.pdf
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
• Workshop at the Brocher Foundation, Hermance,
Switzerland, January 16-18, 2013.
• 22 participants included developers and providers of
e-learning programs from Africa, Europe and North
America as well as funders and users of these
programs
• Resulting Consensus Standards accepted for
publication by the Journal of Medical Ethics JME
(July 2013)
2. Consensus Standards for Introductory e-Learning Courses in Research Ethics and Regulation
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
• The overall goal of the workshop was to begin the process of establishing standards for e-learning programs in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programs.
2.1. OBJECTIVES AND SCOPE
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
• Workshop participants agreed that:
– To maintain the public’s trust in the research enterprise, rigorous education stressing the need to protect individuals who participate in human research is essential.
– Research ethics education programs to promote awareness and appreciation of human research protections must be provided to members of research ethics committees- and to all members of the research team and must be included at the earliest possible stage of professional training.
– Good Clinical Practice (GCP) training is essential for all clinical researchers and support staff. However, since GCP training is very process- and procedure-oriented, it does not provide sufficient instruction in the foundations of clinical research ethics. Thus, GCP courses should always be preceded or accompanied by an introductory course in research ethics.
2.2. Preliminary remarks
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
• Workshop participants agreed that:
– Ethics training should deal with all forms of research involving human participants, not just clinical research.
– Although not the only appropriate method for providing foundational learning opportunities in research ethics, the on-line, e-learning presentation paradigm can be an extremely cost- and time-effective means of achieving this goal.
2.2. Preliminary remarks (cont’d)
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
1. Developer/provider qualifications2. Learning goals
– To raise awareness and understanding of the role of research ethics in the
protection of research participants and in the promotion of high-quality
research that meets the needs of the concerned population.
– To educate those involved in the conduct of research involving human
participants about their roles and responsibilities in the research process.
3. Learning objectives– Program participants will gain the knowledge, understanding and ability to
apply basic concepts in research ethics in the evaluation of common
ethical issues.
– The introductory course will provide a common language and ethical
framework for everybody involved in research.
– A needs assessment will determine more precisely the objectives and
content of the program.
2.3. DRAFT STANDARDS FOR INTRODUCTORY RESEARCH ETHICS E-LEARNING COURSES
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
4. Content• The introductory course includes the following topics:
– Basic concepts: what is ethics, what is research (different types of research), what is
research involving human participants, what is ethics review of research
– A brief history of research ethics
– The roles and responsibilities of all those involved in research
– Conflicts of interests and commitments
– Ethics review by the competent REC
– Fundamental principles and normative framework:
• Scientific accuracy
• Risk-benefit analysis
• Autonomy/informed consent
• Justice
• Vulnerable populations
• Confidentiality and privacy
• Societal, religious and cultural factors
• Local conditions
– Monitoring post-REC approval
2.3. DRAFT STANDARDS FOR INTRODUCTORY RESEARCH ETHICS E-LEARNING COURSES
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
5. Methods– The methods and training material are in line with the learning objectives
and take into account any technical restraints (e.g., low band width)
experienced by potential course participants.
– The introductory course is equivalent to a one-day seminar… Longer times
might be expected if the learner follows all of the hyperlinks provided or
explores all of the suggested additional readings… This limit might also be
exceeded if the language of the course is not the learner’s first language.
– The course provides participants with references and links for more in-
depth study of the material, including resources in local languages where
available. Participants are encouraged to make use of these materials and
to regularly participate in other activities (seminars, workshops, refresher
courses, and informal discussions) to increase their understanding and
skills in research ethics.
2.3. DRAFT STANDARDS FOR INTRODUCTORY RESEARCH ETHICS E-LEARNING COURSES
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
6. Assessment of participants– The course includes an assessment process to ensure that learners have a
satisfactory understanding of the materials presented.
7. Assessment of the course– All learners are given an opportunity to provide the course
developers/providers written feedback about their online learning
experiences (good and bad) with the course. This can be done by using
open-ended questions or by a voluntary, anonymous online survey.
– When feasible, the course provider will seek recognition of the course for
Continuing Professional Development (CPD) credit by the competent
bodies.
2.3. DRAFT STANDARDS FOR INTRODUCTORY RESEARCH ETHICS E-LEARNING COURSES
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
3.1. TRREE: How ?
• Collaborative
• Collegial
• Multi - directional (North – South / South –
North / South – South / North – North)
• African and European perspectives with in
an international vision
• Based on universal ethical principles and a
human rights approach of the issues at
stake
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
3.2. TRREE- Setting priorities (1)
Needs assessment Questionnaire� Conceived, pre-tested and validated
� Approved by RECs in Cameroon, Mali, Tanzania
and Switzerland
– Submitted to ethics committee members in
Cameroon, Mali & Tanzania
– 109 contacted / 255 total in 3 countries
– 68 % response rate (74/109)
Ateudjieu Jérome, Baume Cédric, Joyce Ikingura, Marie Hirtle, Alassane Niaré and Dominique Sprumont, Training Needs Assessment in
Research Ethics Evaluation Among Research Ethics Committees Members in Three African Countries: Cameroon, Mali And
Tanzania, in Developing World Bioethics, September 2009
Dominique Sprumont, Formation de base en éthique de la recherche : retour aux sources avec le projet TRREE, in Bioetica Forum,
Décembre 2009
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
3.2. TRREE- Setting priorities (2)
Summary of Results of the NAQ– 71% of respondents already had some sort
of training in ethics (58 % in Switzerland)
– Priority in terms of content:
• Fundamental principles of ethics
• Applicable normative framework
• How to conduct ethics review
• Informed consent
– Audience
• REC members & researchersAteudjieu Jérome, Baume Cédric, Joyce Ikingura, Marie Hirtle, Alassane Niaré and Dominique Sprumont, Training Needs
Assessment in Research Ethics Evaluation Among Research Ethics Committees Members in Three African Countries:
Cameroon, Mali And Tanzania, in Developing World Bioethics, September 2009
Dominique Sprumont, Formation de base en éthique de la recherche : retour aux sources avec le projet TRREE, in Bioetica
Forum, Décembre 2009
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 2013
3.3. Follow-up
• Elearning.trree.org (online since June 2009)
• New countries included every year (presently 10 with 8
more being drafted, and more for which funding has been
requested)
• New languages available (Chinese and Polish being
drafted / negociation starting for Spanish, Italian and
Russian / GCP module soon available in Portuguese)
• New Modules available: GCP (December 2012); HIV
Vaccine Testing (March 27, 2013)
• New Modules in the pipeline: Medical devices; Human
and Social Sciences Health Research; etc.
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 201332 EDCTP 2011 Annual Meeting
Institut de Droit de la Santé 11 Forum de Etica em Pesquisa Clinica Sao Paulo, August 19, 201340 EDCTP 2011 Annual Meeting
Institut de Droit de la SantéAv. du 1er Mars 26
CH-2000 Neuchâtel
www.unine.ch/ids
Institut de Droit de la Santé
Thank you for your attentionand see you soon on
www.trree.org
Public Health Ethics and Research Ethics Sao Paulo, August 19, 2013